- Alzamend Neuro ( NASDAQ: ALZN ) said on Monday it had received a written response to its meeting request relating to its Type B Pre-Investigational New Drug application from the U.S. Food and Drug Administration.
- The company said the FDA’s response provides a path for its planned clinical development of AL001 for the treatment of bipolar disorder, major depressive disorder and post-traumatic stress disorder.
- AL001 has the potential to deliver benefits of marketed lithium carbonate while avoiding current toxicities associated with lithium.
- Alzamend expects to file INDs for bipolar disorder, MDD and PTSD upon the completion of the current Phase IIA multiple ascending dose study.
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Alzamend Neuro receives positive pre-IND response from FDA for AL001